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Modified Trabeculectomy for Glaucoma Surgery

Primary Purpose

IOP Decreased

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
MODIFIED TRABECULECTOMY
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IOP Decreased

Eligibility Criteria

30 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1ery glacouma

Exclusion Criteria:

  • Previous surgery

Sites / Locations

  • Assiut URecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MODIFIED TRABECULECTOMY

Arm Description

Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane. Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm.

Outcomes

Primary Outcome Measures

IOP
Decreased IOP with normal depth anterior chamber measured by Tonopen

Secondary Outcome Measures

Full Information

First Posted
July 7, 2019
Last Updated
July 11, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04019210
Brief Title
Modified Trabeculectomy for Glaucoma Surgery
Official Title
Modified Trabeculectomy a New Procedure for Glaucoma Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A combination of hypotony, flat anterior chamber and choroidal detachment is the most common complications after filtering surgery. The purpose of this study is to present a new modification in standard trabeculectomy technique to reduce such complications.
Detailed Description
Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane. Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm. The horizontal distance between each point is 3.5 mm Figure(1). The application of the cautery continue till the color of the tissue becomes brown. Then with aid of a 23-gauge needle we penetrate these cauterized points to create 4 holes, each of them is nearly 0.3-0.5 mm in length (the opening of each hole takes the shape of a slit). Through one of these holes iridectomy is done. These holes drain the aqueous under the scleral flap with anatomical preservation of tissue in between. Close the scleral flap by two 10-0 nylon suture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IOP Decreased

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MODIFIED TRABECULECTOMY
Arm Type
Experimental
Arm Description
Recta-angular scleral flap (one half the scleral thickness) is dissected,reaching 2 mm into the cornea. The dissection through the cornea is carried out with great care, leaving only thin corneal stroma over Descement's membrane. Application of direct heat cautery using a prob Imm in size (the prob was heated for 45 seconds) the cautery was applied at 4 points two of them just in front of blue corneal line and the other two at 2 mm anterior to the blue line, the diameter of each point is 1 - 1.5 mm.
Intervention Type
Procedure
Intervention Name(s)
MODIFIED TRABECULECTOMY
Intervention Description
Rectangular scleral flap
Primary Outcome Measure Information:
Title
IOP
Description
Decreased IOP with normal depth anterior chamber measured by Tonopen
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1ery glacouma Exclusion Criteria: Previous surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan 58 Lotfy, Professor
Phone
01020833002
Ext
20
Email
hassaniron57@yahoo.com
Facility Information:
Facility Name
Assiut U
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan 58 Lotfy, Professor
Phone
01020833002
Ext
20
Email
hassaniron57@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

Modified Trabeculectomy for Glaucoma Surgery

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